In September 2012, the US Food and Drug Administration (FDA) sponsored public workshops to present FDA’s draft National Postmarket Surveillance Plan for medical devices (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm) and discuss various aspects of the Plan. As a part of these workshops, discussion was held regarding the development of a broad-based public-private partnership (PPP), the Medical Device Epidemiology Network (MDEpiNet, www.fda.gov/MDEpiNet). In order to assure the development and long-term success of the partnership, a centralized partnership management center needs to be established outside of FDA that is capable of building a sustainable business structure, managing relationships with a broad array of stakeholders, providing scientific leadership in medical device surveillance and epidemiology, and executing high-priority scientific projects with a diverse set of partners

This RFI seeks to gather information from potential collaborators about feasible structures, potential members, financial models, and projected costs for sustained management of the MDEpiNet PPP.

Background

FDA initially proposed the development of the MDEpiNet PPP in a workshop held April 2010. Since that time, FDA has worked with partners on building several projects, and has developed a draft framework for the partnership and its management.

To date, FDA has provided support for individual projects through a variety of mechanisms, including two cooperative agreement FOAs, Developing Innovative Methodologies and Device-Specific Infrastructure through the Medical Device Epidemiology Network: Applications for Medical Countermeasure-Associated Devices (U01) RFA-FD-12-010, and Enhancing post-market surveillance through developing registries for medical device epidemiology (U01) RFA-FD-12-028. While the projects supported under these cooperative agreements support the mission of the FDA and program directives, there is not sufficient opportunity within this pathway for projects to be proposed, prioritized, coordinated, and supported by a wider stakeholder group, as can be accomplished through a public-private partnership. In order to best serve public health, the MDEpiNet PPP requires a centralized coordinating body that would be charged with:

Operational leadership of the PPP

Financial management

Developing scientific consensus among partners

Supporting new scientific projects

Convening partners to develop scientific priorities and consensus

Scientific outreach and dissemination of results

It is assumed that for each of these functions, a multidisciplinary team will be built with membership from MDEpiNet partners. The partnership management center would thus be directly responsible for team management, providing open lines of communication among partners, and equitable means for scientific and operational decision-making.

Information Requested

FDA is interested in obtaining multi stakeholder input related to the operations of the MDEpiNet PPP, to ensure that it is developed in a way that supports not only FDA, but the missions of other participating partners, thus providing the maximum impact on public health. This RFI is focused on better understanding of capabilities and approaches for the management of the MDEpiNet PPP to support the national postmarket surveillance plan. Specifically, FDA requires input related to the following questions:

What role is envisioned for partners representing the patient, government, medical device industry, academia, health care providers, professional organizations, health care payer, and other sectors, and what are the parameters for their membership in the MDEpiNet PPP?

Which additional partnership sectors should be represented, if any, and are there specific groups without whom the MDEpiNet PPP would not meet its mission?

How would governance balance the desire for a comprehensive representative body against the need for nimble operations, usually accomplished through a small empowered team?

What financial model(s) would best support the startup and sustained management of the PPP through the partnership management center?

What are the ideal project proposal, selection, funding, and management models that would allow for appropriate buy-in and coordination, while allowing for scientific independence of investigators?

What is the projected annual cost of operations, and what would be the ideal breakdown of federal and private funding to meet those needs?

Confidentiality

Responses to this RFI are voluntary. Any personal identifiers (e.g., names, addresses, email addresses, etc.) will be removed when responses are compiled. Please do not include proprietary, classified, confidential, or sensitive information in your response. Replies to individual topics are optional, and anonymous responses are permitted. The information provided will be analyzed and may appear in various reports. You will not receive individualized feedback on responses. The United States government may use any non-proprietary technical information in any resultant solicitation(s).

How to Submit a Response

Responses to this RFI are due January 11, 2013 by 11:59 PM Eastern Time. Responses should be limited to ten pages and marked with this RFI identifier NOT-FD-13-001 in the subject line and if you are willing to do so, please also provide the following:

This RFI is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it. Please note that the U.S. Government will not pay for the preparation of any comment submitted or for its use of that comment.